软肝抗纤方治疗慢性乙型肝炎的疗效观察

Clinical Observation of Ruangan Kangxian Formula in Treating Chronic Hepatitis B and Improving Liver Function

目的 探讨软肝抗纤方治疗慢性乙型肝炎(Chronic hepatitis B,CHB)的临床效果,并分析对患者肝功能的影响。方法 选取2018年1月—2020年12月期间华北石油管理局总医院门诊收治的172例CHB患者作为观察对象,采用随机数字表法将患者分为2组,对照组86例服用恩替卡韦和复方益肝灵片,观察组86例服用恩替卡韦和中药软肝抗纤方,疗程为3个月。观察并分析用药前与用药后患者的中医症候积分[纳呆、乏力、胁痛、腹胀和便溏]、肝纤维化指标[透明质酸(Hyaluronic acid, HA)、层黏蛋白(Laminin, LN)、IV型胶原(Type IV collagen, C-IV)和肝硬度值(Liver stiffness measurement, LSM)]、氧化应激指标[丙二醛(Malondialdehyde, MDA)、超氧化物歧化酶(Superoxide dismutase, SOD)和晚期蛋白氧化产物(Advanced oxidation protein products, AOPPs)]和肝功能指标[丙氨酸氨基转移酶(Alanine aminotransferase, ALT)、天门冬氨酸氨基转移酶(Aspartate aminotransferase, AST)、谷氨酰转肽酶(γ-glutamyltranspeptidase, GGT)和总胆红素(Total bilirubin, TBil)]变化情况,比较两组病毒学指标[乙肝病毒脱氧核糖核酸(Hepatitis B virus-deoxyribonucleic acid, HBV-DNA)转阴率、乙肝e抗原(Hepatitis B e antigens, HBeAg)血清学转换率],评估疗效。结果 治疗后两组患者各项中医证候积分均较治疗前下降,差异有统计学意义(P<0.05);且观察组各项中医证候积分均较对照组降低,差异有统计学意义(P<0.05)。治疗后两组患者肝纤维化指标均较治疗前降低,差异有统计学意义(P<0.05);且观察组HA、LN、C-IV和LSM指标明显低于对照组,差异有统计学意义(P<0.05)。治疗后两组患者氧化应激MDA、AOPPs指标均较治疗前明显降低,SOD指标均较治疗前明显升高,差异有统计学意义(P<0.05);且观察组MDA、AOPPs指标明显低于对照组,SOD指标明显高于对照组,差异有统计学意义(P<0.05)。治疗后两组患者肝功能指标均较治疗前降低,差异有统计学意义(P<0.05);两组患者肝功能指标组间比较,差异无统计学意义(P>0.05)。治疗后观察组HBV-DNA转阴率和HBeAg血清学转换率高于对照组,差异有统计学意义(P<0.05)。治疗后观察组治疗总有效率为94.19%(81/86)明显高于对照组84.88%(73/86),差异有统计学意义(P<0.05)。结论 基于抗病毒药物恩替卡韦,辅以软肝抗纤方治疗CHB抗病毒效果显著,疗效突出,能抑制肝纤维化,改善氧化应激和肝功能。

Objective To investigate the clinical effect of Rugan Kangxian Formula on chronic hepatitis B(CHB)and liver function.Methods A total of 172 CHB patients who were treated in the Outpatient Department of Huabei Petroleum General Hospital from January 2018 to December 2020 were included and randomized into the control group(n=86,entecavir and Compound Yiganling Tablets,3 months)and observation group(n=86,entecavir and Rugan Kangxian Formula,3 months)with the random number table method.The scores of traditional Chinese medicine(TCM)symptoms[anorexia,lack of strength,hypochondriac pain,abdominal distension,and loose stool],liver fibrosis indexes[hyaluronic acid(HA),laminin(LN)and type IV collagen(C-IV),liver stiffness measurement(LSM)],oxidative stress indexes[malondialdehyde(MDA),superoxide dismutase(SOD),and advanced oxidation protein products(AOPPs)],and liver function indexes[alanine aminotransferase(ALT),aspartate aminotransferase(AST),(glutamyl) transpeptidase(GGT),and total bilirubin(TBil)]were observed before and after treatment.The virological indexes[hepatitis B virus-deoxyribonucleic acid(HBV-DNA)-negative conversion rate and sero-conversion rate of hepatitis B envelope antigen(HBeAg)]were compared between the two groups and the efficacy was evaluated.Results After treatment,the TCM symptom scores were lower than those before treatment in both groups(P<0.05)and were lower in the observation group than in the control group(P<0.05).After treatment,the liver fibrosis indexes were lower than those before treatment in the two groups(P<0.05)and the levels of HA,LN,C-IV,and LSM in the observation group were lower than those in the control group(P<0.01).After the medication,the levels of MDA and AOPPs decreased and SOD increased in the two groups compared with those before treatment(P<0.05).In addition,the levels of MDA and AOPPs were lower in the observation group than in the control group,while SOD was higher in the observation group than in the control group(P<0.01).After treatment,the liver function indexes were lower than those before treatment in both groups(P<0.05)and showed no significant difference between the two groups(P>0.05).The HBV-DNA-negative conversion rate and HBeAg sero-conversion rate in the observation group were higher than those in the control group(P<0.05).The total effective rate of the observation group was 94.19%(81/86),as compared with the 84.88%(73/86)in the control group(P<0.05).Conclusion The combination of entecavir and Rugan Kangxian Formula is effective for CHB,which can inhibit liver fibrosis,alleviate oxidative stress,and improve liver function.